Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 12:22 PM
Study NCT ID:
NCT03992560
Status:
RECRUITING
Last Update Posted:
2023-03-10
First Post:
2019-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Randomised Multi-centre Trial Comparing cArdiac MRI Guided CRT Versus Conventional CRT Implantation in Patients With Ischaemic Cardiomyopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 218}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2026-07-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-09', 'studyFirstSubmitDate': '2019-06-18', 'studyFirstSubmitQcDate': '2019-06-19', 'lastUpdatePostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '>15% reduction in end systolic volume', 'timeFrame': '6 months', 'description': '\\>15% reduction in end systolic volume derived from 2-dimensional transthoracic echocardiogram at 6 months post CRT implant'}], 'secondaryOutcomes': [{'measure': '5% absolute increase in left ventricular ejection fraction', 'timeFrame': '6 months', 'description': '5% absolute increase in left ventricular ejection fraction as derived from 2D echocardiogram'}, {'measure': '>10% reduction in end diastolic volume', 'timeFrame': '6 months', 'description': '\\>10% reduction in end diastolic volume as derived from 2D echocardiogram'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': "The purpose of the study is to determine whether MRI guided CRT implantation (using Siemen's software prototype) is superior to standard treatment in terms of CRT response. Data will be collected at enrolment, implant, pre-discharge, 6 weeks and 6 months. The total duration of the investigation will be 6 months.\n\nThe primary endpoint will be assessed by calculating the difference in the proportion of responders (\\>15% reduction in end systolic volume derived from 2-dimensional transthoracic echocardiogram at 6 months post CRT implant)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18yrs of age\n* Standard indication for CRT-P or CRT-D according to European Society of Cardiology (ESC)/European Heart Rhythm (EHRA) guidelines.1\n* Stable on optimal medical therapy for at least 3 months\n* Ischaemic aetiology\n* Patients with atrial fibrillation can be included\n\nExclusion Criteria:\n\n* Any contraindication to pacing /implantable cardioverter-defibrillator (ICD) implant\n* Requirement for endocardial pacing\n* Contraindication to gadolinium contrast enhanced cardiac Magnetic Resonance (MR) scanning\n* Significant claustrophobia\n* Significant renal impairment with estimated glomerular filtration rate (eGFR) \\<30 mL/min/1.73m2\n* Existing pacemaker or ICD system or extraction of a CRT system within the last 6 months\n* Participation in other studies with active treatment/ investigational arm\n* Pregnant or planning to become pregnant in the next 7 months'}, 'identificationModule': {'nctId': 'NCT03992560', 'acronym': 'TACTIC CRT', 'briefTitle': 'A Prospective Randomised Multi-centre Trial Comparing cArdiac MRI Guided CRT Versus Conventional CRT Implantation in Patients With Ischaemic Cardiomyopathy', 'organization': {'class': 'OTHER', 'fullName': "Guy's and St Thomas' NHS Foundation Trust"}, 'officialTitle': 'A Prospective Randomised Multi-centre Trial Comparing cArdiac MRI Guided CRT Versus Conventional CRT Implantation in Patients With Ischaemic Cardiomyopathy', 'orgStudyIdInfo': {'id': '1.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard CRT implantation'}, {'type': 'EXPERIMENTAL', 'label': 'MRI guided CRT implantation', 'interventionNames': ['Device: Guide CRT Software Prototype']}], 'interventions': [{'name': 'Guide CRT Software Prototype', 'type': 'DEVICE', 'description': 'The medical device in the trial is a software programme that allows image fusion of previously acquired MRI images with real-time X-Ray fluoroscopic images in the cardiac catheter laboratory. We are able to use the MRI information to assess the best location to place the left ventricular lead for a CRT device and then superimpose this location onto the real-time X-Ray fluoroscopic images during the left ventricular lead implantation', 'armGroupLabels': ['MRI guided CRT implantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE1 7EH', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Humra Chadwick', 'role': 'CONTACT', 'email': 'humra.chadwick1@gstt.nhs.uk', 'phone': '02071887188', 'phoneExt': '56217'}, {'name': 'Aldo Rinaldi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Guys and St Thomas NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guy's and St Thomas' NHS Foundation Trust", 'class': 'OTHER'}, 'collaborators': [{'name': "King's College London", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}